Preparation and quality control
Preparation of the drug should be simple and require relatively little manipulation on the part of the preparer. Procedures with more than 3 steps generally do not meet this requirement. In addition, no complicated equipment or time consuming steps should be involved.
If radiopharmaceuticals are manufactured in-house, it is essential that quality control be performed on every batch of drug prepared to insure that each individual preparation that will produce a high-quality image while minimizing the radiation dose to the patient. Alltered biodistribution caused by an improperly prepared drug can destroy image quality and have a significant impact on the internal radiation dose conferred to the patient.
Criterion: One must be able to answer "YES" to the question, "Would I inject this into my mother?" Without performing quality control testing, it's impossible to know how well the product will perform.
Stephen Karesh, PhD. |
Last Updated: August 14, 1996 |